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Apr 27, 2013
04/13
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the repercussions of congressional inaction are clear that the fda. the agency will undertake 2100 fewer inspections which is at an 18% decline compared to last year. the implementation of the 2011 food safety modernization act will be further delayed meaning we can continue to expect an estimated cost of $75 billion annually in lost productivity and medical expenses and new drugs that reduce pain and sustain life will take longer to review and approve robbing 6 americans of improved quality of life and more time with the loved ones, by cutting services and decreasing investments critical to our economic competitiveness fees across the board budget cuts having a severe impact across all sectors of the economy. we must replace reckless, indiscriminate cuts with a renewed focus on jobs, economic growth and a balanced fiscal package that creates long-term deficit reduction. i just want to say i look forward to a day soon when chairman rogers and i can work together in a bipartisan way and really address serious issues as a result of sequestration, bring
the repercussions of congressional inaction are clear that the fda. the agency will undertake 2100 fewer inspections which is at an 18% decline compared to last year. the implementation of the 2011 food safety modernization act will be further delayed meaning we can continue to expect an estimated cost of $75 billion annually in lost productivity and medical expenses and new drugs that reduce pain and sustain life will take longer to review and approve robbing 6 americans of improved quality of...
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Sep 23, 2013
09/13
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ALJAZAM
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>> the principals adjudicated this with the fda in 2009. in december 10, 2010, the courts determined that the e-cig is actually a tobacco product. our association is adamant that the e-cig as a tobacco product be regulated as a tobacco product and prohibit sales and marketing to kids. our position is on television, radio and sporting events that it not be advertised as we are a tobacco product and there should be not be advertising at sports events. >> we'll get into the regulation later in the show. what about fill sof if i c fillf i canally? are kids drawn to flavors like vanilla and chocolate? >> kids are drawn to a lot of things. kids try other drugs and alcohol. this study did not draw a link between kids experimenting and then kids actually using. so, again, the purpose of the study, i really don't know. you would think there's a correlation. yes, there's 10% of kids using e significants and 6.4% are hard-core users of conventional cigarettes. what the cdc is trying to disseminate is not clear at all. >> you talked about the research
>> the principals adjudicated this with the fda in 2009. in december 10, 2010, the courts determined that the e-cig is actually a tobacco product. our association is adamant that the e-cig as a tobacco product be regulated as a tobacco product and prohibit sales and marketing to kids. our position is on television, radio and sporting events that it not be advertised as we are a tobacco product and there should be not be advertising at sports events. >> we'll get into the regulation...
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Sep 5, 2013
09/13
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ALJAZAM
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eye 115
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the fda's former boss told congress in testimony, that fda has all the tools that they need to properly regulate this industry and no one last more skin in this game than our organization. we represent consumers. i take vitamins and dietary supplements, family friends and colleagues we want the best advertised produced and marketed supplements that can be had. and the numbers just simply do not show that they are incredibly dangerous. they have a fantastic safety profile. they really do. >> john, to the point, the rate of reported incidents from dietary supplements does seem pretty low from 2008 through 2011 the fda received 6307 reports of health problems for dietary supplements, in 2008 alone there were 525,000 prorts of problems with -- is problems with fda approved drugs. so in that context john, is it really that big of a deal? >> yeah, let's put it in a couple of different ways to look at that. first of all the reported incidents are only times when people are absolutely sure that a problem was caused by a dietary supplement but most people don't know. when they come down with an
the fda's former boss told congress in testimony, that fda has all the tools that they need to properly regulate this industry and no one last more skin in this game than our organization. we represent consumers. i take vitamins and dietary supplements, family friends and colleagues we want the best advertised produced and marketed supplements that can be had. and the numbers just simply do not show that they are incredibly dangerous. they have a fantastic safety profile. they really do....
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Nov 30, 2013
11/13
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ALJAZAM
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eye 83
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where the fda is more concerned. basically, when the company he says that you have this particular -- says you have this particular result does it mean anything in regard to your health for sure, is there anything you can do about it? and the answer is in most cases no. but this is as i say the first citizen in an pon going process of developing person genomic medicine over time. it is just a process, a way for us to learn and i think fda is process. >> it is a new way of looking at health and predicting the future. and hank, the fda says, in its warning letter to 23 and me, a result may be used by a patient to self-manage. serious concerns are raised if test results are not adequately understood by patients or incorrect test results were reported. they bring up the bracca gene, somebody may get a mastectomy or get treatments they don't need or if there's a false prove. somebody shouldn't get a mastectomy by not checking with a doctor would they? >> well it's a big country. i wouldn't say never. what about a b rc 1 o
where the fda is more concerned. basically, when the company he says that you have this particular -- says you have this particular result does it mean anything in regard to your health for sure, is there anything you can do about it? and the answer is in most cases no. but this is as i say the first citizen in an pon going process of developing person genomic medicine over time. it is just a process, a way for us to learn and i think fda is process. >> it is a new way of looking at...
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Nov 15, 2013
11/13
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CSPAN2
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the user fees are an essential component of the if fda's funding -- fda's funding. they help to insure the american public has access to safe and effective health care products. for generics at the time of enact amount, there was a backlog of over 2500 drugs. these essential products typically cost 50-70% less than their brand name counterparts and have provided an estimated $1 trillion in savings over the past decade. it's important that american consumers have access to these safe, effective and low-cost alternatives more quickly which is why the provisions in the generic drug user fee agreement were so important, because it gave fda the resources today need to make sure that happens. so i'm interested to hear on that progress today. the bill also gives fda additional tools to insure the safety of the global drug supply chain as requireing registration for foreign and domestic drug establishments, administrative detention for adulterated or misbranded drugs and increased penalties for counterfeit drugs. the additional authorities allow fda to strengthen cooperatio
the user fees are an essential component of the if fda's funding -- fda's funding. they help to insure the american public has access to safe and effective health care products. for generics at the time of enact amount, there was a backlog of over 2500 drugs. these essential products typically cost 50-70% less than their brand name counterparts and have provided an estimated $1 trillion in savings over the past decade. it's important that american consumers have access to these safe, effective...
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Nov 15, 2013
11/13
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CSPAN2
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fda was kind of to send dr. richard -- thank you, for the center for drug evaluation and i want to thank you very much because i know the budget are very tight, but to have folks that are leaders that fda be able to interact directly with folks in my stay was greatly appreciated, so thank you. and the conference focused a lot on the future of drug approval. so we are pleased that the federal laws are working well. i think the number one fear of everyone, the topic of this conference turns to sequestration. because people are rather surprised that even the fda relies a lot on user fees, the user fees are subject to sequestration. this is not smart. some of the announcements i've seen come and tell me if these numbers are right, that to your budget, i don't know if this is the entire fda budget or just your section, that in fiscal year 2013 you were subject to sequestration of $209 million, and on top of that 85 million in private funding. the user fees were sequestered at the same time. and then in fiscal year '1
fda was kind of to send dr. richard -- thank you, for the center for drug evaluation and i want to thank you very much because i know the budget are very tight, but to have folks that are leaders that fda be able to interact directly with folks in my stay was greatly appreciated, so thank you. and the conference focused a lot on the future of drug approval. so we are pleased that the federal laws are working well. i think the number one fear of everyone, the topic of this conference turns to...
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Apr 26, 2013
04/13
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CSPAN2
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economy as is a strong fda. history shows that when the public trusts fda's oversight in the products we regulate, these industries flourish. conversely, when products cause serious high harm, it can resuln severe economic damage across the industry involved to fenders and nonoffenders alike. i want to mention some of our measurable accomplishments this past year. in 2012 fda approved 39 novel medicines, the highest number in over a decade, and the majority of these drugs were approved in the united states before anywhere else in the world. some in as little as three-and-a-half months. the number of drug shortages were cut in half compared to 2011. we successfully turned around a decade of lengthening medical device reviews and backlogs. working together with 45 state and territorial partners, we conducted more than 158,000 inspections of tobacco retailers to insure that they're not selling cigarettes or smokeless tobacco products to minors, and we published our first two food safety proposed rules as part of th
economy as is a strong fda. history shows that when the public trusts fda's oversight in the products we regulate, these industries flourish. conversely, when products cause serious high harm, it can resuln severe economic damage across the industry involved to fenders and nonoffenders alike. i want to mention some of our measurable accomplishments this past year. in 2012 fda approved 39 novel medicines, the highest number in over a decade, and the majority of these drugs were approved in the...
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Apr 30, 2013
04/13
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fda tells me they will be. i just think it will come more slowly. -- congressted fda wanted fda to move into a more scientific and rigorous and modern way of looking at food safety, and they are going to be forced to do it slower than they have in the past. food we are talking about safety at the fda's role in that. tomorrow, as part of our "spotlight on magazines" series, we will talk to a abouter from "harper's" going undercover at a slaughterhouse. guest: i would be curious to see what the data is on that. cdc had been using numbers that were about 10 years old looking at the numbers of foodborne illness cases. the numbers went down a bit. every year that cdc and usda produces a report that shows where foodborne illnesses are going, some numbers have gotten a pretty drastically. e. coli, which we associate with ground beef because of the jack-in-the-box outbreak in the 1990s in the northwest, e. coli actually went down a lot. the beef industry did a remarkable turnaround in terms of shifting the way that it
fda tells me they will be. i just think it will come more slowly. -- congressted fda wanted fda to move into a more scientific and rigorous and modern way of looking at food safety, and they are going to be forced to do it slower than they have in the past. food we are talking about safety at the fda's role in that. tomorrow, as part of our "spotlight on magazines" series, we will talk to a abouter from "harper's" going undercover at a slaughterhouse. guest: i would be...
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Dec 2, 2013
12/13
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ALJAZAM
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yet the fda allows that to go forward as a test. i suggest to you that the false-negative rate for the test that is being offered by 23 and me is considerably lower. the fda is over stepping their authority here. it's a matter of caveat emptor. should a person be able to self treat without consi consulting a doctor. >> 23 and me should require that you go through a medical professional. the same way if you get a mri scan for your brain. it's worked in some sector of the economy and it's not worked in other areas of the world. we have quacks and it's confusing and complicated and they need help. and putting it on a web page so people can read it is not a guarantee that anyone is going to read it or if they read it understand it. >> ron have the half million customers that have been served by 23 and me already, has anyone been harmed by their results? >> i have been looking around to find examples and i can't find any. there has to be someone that has complained by something obviously it's not a huge problem as far as i can tell there
yet the fda allows that to go forward as a test. i suggest to you that the false-negative rate for the test that is being offered by 23 and me is considerably lower. the fda is over stepping their authority here. it's a matter of caveat emptor. should a person be able to self treat without consi consulting a doctor. >> 23 and me should require that you go through a medical professional. the same way if you get a mri scan for your brain. it's worked in some sector of the economy and it's...
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Jan 12, 2013
01/13
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at fda. mike taylor has had a relationship with the government for a very long time. at usda and accuse fda and monsanto. people in my office have been working on it for 20 years. and have never seen any reason to believe that there has been an inappropriate relationship or some sort of inappropriate amount of influence being exerted by monsanto. mike taylor is dedicated to public health. we believe the agency is working as best it can to prevent food borne illness. there are issues, certainly, about the kinds of products being produced for consumers on these highly processed foods, foods that contain a lot of soy and other ingredients but not as naturally occurring in those foods -- that are not as naturally occuring in those foods. having said that, i do not believe that is being information being withheld by the fda because of that relationship. the best way to bring that number, 48 million illnesses a year, down. host: well margaret hamburg have to go to congress and explain doese new rul
at fda. mike taylor has had a relationship with the government for a very long time. at usda and accuse fda and monsanto. people in my office have been working on it for 20 years. and have never seen any reason to believe that there has been an inappropriate relationship or some sort of inappropriate amount of influence being exerted by monsanto. mike taylor is dedicated to public health. we believe the agency is working as best it can to prevent food borne illness. there are issues, certainly,...
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Nov 3, 2013
11/13
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FOXNEWSW
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they don't have to report to fda. maybe they're not getting enough raw material just enough to make it on time. that's this whole cycle that has continued. fda this week announced they're going to really look into this and have a real open communication with all of these manufacturers. they want to put pressure on them to make sure this doesn't happen again and interesting part about the whole thing is there's a new website now where all of the hospitals can come in and communicate so let's say your hospital has more propofol than mine. i can get in and say can someone help and you can work together. if they decide to stop a medication or not make it anymore for whatever reason, they have to report to fda so there will be advance notice to the pharmacy. >> that's a good thing. >> absolutely. a lot of times they might have patients come in saying the medication is too expensive. i can't get it. what do i do? they go to canada, et cetera. i said this before. if you are going to go out of the country which is not a good
they don't have to report to fda. maybe they're not getting enough raw material just enough to make it on time. that's this whole cycle that has continued. fda this week announced they're going to really look into this and have a real open communication with all of these manufacturers. they want to put pressure on them to make sure this doesn't happen again and interesting part about the whole thing is there's a new website now where all of the hospitals can come in and communicate so let's say...
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Jul 20, 2013
07/13
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CSPAN2
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eye 73
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maybe two of our panelists talked about fda policy so i should just defer to them. >> the fda. the food and drug administration, often touted to be the best in the world's. other countries follow the rules very often and there are really good people who work there. as a matter-of-fact especially under democratic administrations, much better. the colleague who i wrote the book with, genetic justice, used to work for the aclu. you know that organization. and she went and was hired by the fda to be assistance to the director. she is a very good progress of the individual but efta like any other federal agency has political pressures on them, political pressures. that is the problem. we can't always sort out what those political pressures are, behind-the-scenes, some country might ban a chemical from exposure but the fda says no, we don't have enough information yet to ban it. you knows that being pressured from an industry group saying if you ban this chemical our profits are going to go down. it is a mixed bag. very good people work there, they can always decide things. it has to
maybe two of our panelists talked about fda policy so i should just defer to them. >> the fda. the food and drug administration, often touted to be the best in the world's. other countries follow the rules very often and there are really good people who work there. as a matter-of-fact especially under democratic administrations, much better. the colleague who i wrote the book with, genetic justice, used to work for the aclu. you know that organization. and she went and was hired by the...
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May 5, 2013
05/13
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>> guest: yes, the fda did. in fact, one of my sources actually died from cancer, and she had taken epo. it's just astonishing, almost every time i turned around, someone was passing away. i think all of us know someone who has beat cancer or has succumbed to it. but the fda, interestingly enough, doesn't have a lot of power. we would hope that they would, but they don't have the authority to just yank a drug off of the shelves. >> host: why not? >> guest: a lot of times in this book, for example, i found out that many attorneys who are overseeing the fda at the time would squash the fda staff members. and one attorney if -- in particular, by the name of daniel troy, and he now works for a pharmaceutical company. but you had this revolving door in either the department of justice, fda or any other regulator, and it would make your head spin, frankly, to see how quickly these people go between regulating and being regulated. so oftentimeses they go back to great jobs, much better paying jobs, you know, defending
>> guest: yes, the fda did. in fact, one of my sources actually died from cancer, and she had taken epo. it's just astonishing, almost every time i turned around, someone was passing away. i think all of us know someone who has beat cancer or has succumbed to it. but the fda, interestingly enough, doesn't have a lot of power. we would hope that they would, but they don't have the authority to just yank a drug off of the shelves. >> host: why not? >> guest: a lot of times in...
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Nov 3, 2013
11/13
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FOXNEWSW
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the fda is talking about a major public threat. turns out there's a major shortage in prescription drugs so which ones and how worried should we be? >> we shouldn't be worried. this is good news. i'm glad we're opening with positive news. fda is coming down on manufacturers since 2010, we have had over 546 drugs that are really short, that has put pharmacies in a lot of trouble and frustrated patients. a lot of the shortages of medications, propofol, tamiflu, on and on, it's because manufacturers may not make enough profit, they don't necessarily to have to report to the fda, and maybe they're not getting enough raw material to make it on time. so this cycle has continued. fda this weekend said they're going to really look into this, have an open communication with all of these manufacturers. they want to put pressure on them to make sure this doesn't happen again, and the interesting part about the whole thing is there's a new website where all of the hospitals can come in and communicatcommunica. let's say your hospital has more
the fda is talking about a major public threat. turns out there's a major shortage in prescription drugs so which ones and how worried should we be? >> we shouldn't be worried. this is good news. i'm glad we're opening with positive news. fda is coming down on manufacturers since 2010, we have had over 546 drugs that are really short, that has put pharmacies in a lot of trouble and frustrated patients. a lot of the shortages of medications, propofol, tamiflu, on and on, it's because...
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May 1, 2013
05/13
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KNTV
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one more major development from the fda. late today it announced it is approving the plan "b" morning-after pill without a prescription for anyone 15 and older who can produce an identification. earlier this month, a federal judge ruled there should be no age restrictions and gave the fda 30 days to act. brian? >> tom costello with all things fda related from washington tonight. tom, thanks. >>> new numbers out tonight about home prices. the highest annual jump in nearly seven years. 9.3% according to one closely watched index. and that's in all 20 of the biggest cities in this country. one reason prices are rising so fast? inventory, pure and simple. there is very little out there to buy. with fewer new listings than we see, especially during this time of year. >>> still ahead for us as we continue tonight, taking down historic churches to put up a new stadium. it's a wrenching problem involving big money and progress and the wrecking ball. >>> and later, what happened today to the eternal flame at the jfk burial site. >>>
one more major development from the fda. late today it announced it is approving the plan "b" morning-after pill without a prescription for anyone 15 and older who can produce an identification. earlier this month, a federal judge ruled there should be no age restrictions and gave the fda 30 days to act. brian? >> tom costello with all things fda related from washington tonight. tom, thanks. >>> new numbers out tonight about home prices. the highest annual jump in...
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you don't trust government and the fda is the one regulating do you trust the fda to be good regulator. >> the fda made bad but the idea of regulations oranarchy, no. it is common sense is a potent drug and have devastating consequences and the idea of treating it like a piece of gum is preposterous. >> john, is there a role for government protecting us from bad or dangerous medications? >> i don't think so. sex, druggings, they are serious subjects and why do we leave to the government to protect us from these things? this is the job of pafts and not the job . government. >> we are not leaving it to them john. they can assist the parent. >> don't want tha help. >> lib tarianism doesn't mean devoid of all laws. i am one but i don't think you can go in the movie theater and yell fire. >> sabrina? >> we are talking about childrenhe age of 18. that is very different. i am concerned about the fda overregulate not releasing druggings that may help people. but we are talking about 14 and 15 year old kids and accepting a policy of having sex before thinking . consequences. >> rick, you are ri
you don't trust government and the fda is the one regulating do you trust the fda to be good regulator. >> the fda made bad but the idea of regulations oranarchy, no. it is common sense is a potent drug and have devastating consequences and the idea of treating it like a piece of gum is preposterous. >> john, is there a role for government protecting us from bad or dangerous medications? >> i don't think so. sex, druggings, they are serious subjects and why do we leave to the...
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107
Sep 12, 2013
09/13
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ALJAZAM
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eye 107
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the product not approved by the fda, but all constituents have been approved by the fda. it has engendered a lot of conversation. >> what are the five ingredients? >> profalean glycol -- that is approved by the epa for use. you have different levels of nicotine. it is heated to a water vapor and you inhale it. the exhale is a water vapor as well. i could put 50 people in this room, and you really won't smell anything. >> but i want to hear from dr. glass. what are your concerns about these ingredients. >> there have been a few studies that have measured what is in the e-cigarettes, there is formaldehyde, carcinogens and heavy metals. so they are delivering much lower levels of toxic chemicals than a conventional cigarette. so yes, they are less dangerous than a conventional cigarette, but they are still delivering a wide range of substances that are toxic. ten of the chemicals are actually on -- here in california are called the proposition 65 list of known carcinogens that require consumer warnings. in addition the claim that e-cigarettes don't pollute the air around the
the product not approved by the fda, but all constituents have been approved by the fda. it has engendered a lot of conversation. >> what are the five ingredients? >> profalean glycol -- that is approved by the epa for use. you have different levels of nicotine. it is heated to a water vapor and you inhale it. the exhale is a water vapor as well. i could put 50 people in this room, and you really won't smell anything. >> but i want to hear from dr. glass. what are your...
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117
Jan 6, 2013
01/13
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KRCB
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when the fda aproves a drug when the fda aproves a drug what the manufacturer has to establish is that the new drug is better than nothing. >> are we talking about wikperdol? >> that's one of the drugs. this is a whole category but that's the one in the study. if you found this is true, the newer drug will claim it's an improvement or suggested an improvement, plus the impact of the advertising programs and the solicitation of doctors from brands? i don't want to -- we're not here to fault brand drugs and we'll explain that in a minute. but, there is no advertising for the drugs that we're talking about here. the generic drugs. >> very little promotion of generic drugs to consumers or doctors. >> because when the brand drugs goes off patent, you get a variety of generic companies. it's per missibility and for all genarks to enter the competition, correct? >> for the first 6 months, the first generic manufacturer to challenge the patent has exclusivity for 6 months. this is very important because this was created by the hatch wax man act in 1984. and it creates a 6 month exexclusivity f
when the fda aproves a drug when the fda aproves a drug what the manufacturer has to establish is that the new drug is better than nothing. >> are we talking about wikperdol? >> that's one of the drugs. this is a whole category but that's the one in the study. if you found this is true, the newer drug will claim it's an improvement or suggested an improvement, plus the impact of the advertising programs and the solicitation of doctors from brands? i don't want to -- we're not here...
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456
Jun 8, 2013
06/13
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KNTV
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we don't approve hope at the fda. >> reporter: until two years ago, dr. timothy cote was the director of the fda's division for drugs that treat rare or so-called orphan diseases. the fda would not talk to us because the agency is not allowed to discuss any drug's application for approval. but dr. cote did agree to explain the policies in general. >> they want to see the real data. they don't want to hear your belief. they don't want to hear how you feel about the drugs. they want to see the facts. >> reporter: sometimes randomized clinical trials don't make sense. when do we put common sense and science in tandem? >> i think the common sense and science are in tandem already. >> reporter: what's more, dr. cote says, there is a way to get access to unapproved drugs. it's called compassionate use. and requires doctors to get special approval from the fda on behalf of their patients. >> that's exactly what compassionate use is for. is when you have a fatal disease and you have an opportunity and you think something might work. we're not having babies die be
we don't approve hope at the fda. >> reporter: until two years ago, dr. timothy cote was the director of the fda's division for drugs that treat rare or so-called orphan diseases. the fda would not talk to us because the agency is not allowed to discuss any drug's application for approval. but dr. cote did agree to explain the policies in general. >> they want to see the real data. they don't want to hear your belief. they don't want to hear how you feel about the drugs. they want...
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87
Jun 14, 2013
06/13
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CSPAN2
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eye 87
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and if the fda agrees that the original formulation was removed for safety reasons and the fda is precluded from approving generic competitors without comparable abuse-deterrent formulations. and in the absence of generic versions, then patients are forced to pay higher monopoly prices for extended time periods which in turn has the potential to decrease patient access to these drugs. um, have you heard about this? >> yes. and this is back to one of -- the discussion of the balances that are, you know, that need to be kept in mind as we think about addressing this abuse crisis. so in this case we have the necessary balance between incentivizing the development of abuse-deterrent formulations that work. we want to have opioids in formulations that deter abuse. that, i just believe that's everyone's best interest, to find a way to incentivize that while at the same time recognizing the impact and importance of the generics in the u.s. market. currently, well more than 75% of the total prescriptions, etc. accomplishing that balance is something that the fda's thinking and working very hard on.
and if the fda agrees that the original formulation was removed for safety reasons and the fda is precluded from approving generic competitors without comparable abuse-deterrent formulations. and in the absence of generic versions, then patients are forced to pay higher monopoly prices for extended time periods which in turn has the potential to decrease patient access to these drugs. um, have you heard about this? >> yes. and this is back to one of -- the discussion of the balances that...
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Nov 8, 2013
11/13
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WMPT
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called fda preemption. bars lawsuit against some fda approved devices. >> they have given it a pass. >> reporter: the attorney has ñr been fighting device and drug cases that involve the fda for almost three decades and says law firms turn down preemption on a daily bases. it's ones you put insides the body, the assure coils or pacemaker or pump. the ideas is that the companies that make them get protection from the fda and can't be sued because the agency scrutinizes devices. atrneys and patient advocates consider ate flawed concept. >> this is $100 billion industry. there is simply not enough money or time or people this the fda to give it the oversight or attention. >> reporter: that comes during development, and approval before devices hit the market and long-term testing. even if a product or device turns out the be problematic, preemption means if you took them to court the case would likely be thrown out. they drafted one of the country's most famous activists to help with the cause. >> let's put th
called fda preemption. bars lawsuit against some fda approved devices. >> they have given it a pass. >> reporter: the attorney has ñr been fighting device and drug cases that involve the fda for almost three decades and says law firms turn down preemption on a daily bases. it's ones you put insides the body, the assure coils or pacemaker or pump. the ideas is that the companies that make them get protection from the fda and can't be sued because the agency scrutinizes devices....
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64
Dec 14, 2013
12/13
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eye 64
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the fda is focused on patient safety. august, the fda put out technical guidance on wireless medical devices. we assisted them for both ringing those products to market. every app does not have to come through us. it may or may not have to go through the fda. any platform that is a transmitter would be included. when it comes to privacy and security what is the fcc role? >> that is a good question. we work closely with the national coordinator. we have not staked out a specific role when it comes to help i.t. there is the health affordability and accountability act. that is about the privacy and security of health care but also administrative transactions. about your partnership and how you keep getting -- from getting in each other's way? >> we understand what each other do. my first month at the fcc was a lot about explaining. >> how is the fcc involved in health care? broadband fore rural health care organizations. that is part of the world program and the connect program. that is more and more rural and other provider
the fda is focused on patient safety. august, the fda put out technical guidance on wireless medical devices. we assisted them for both ringing those products to market. every app does not have to come through us. it may or may not have to go through the fda. any platform that is a transmitter would be included. when it comes to privacy and security what is the fcc role? >> that is a good question. we work closely with the national coordinator. we have not staked out a specific role when...
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363
Nov 26, 2013
11/13
by
KGO
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eye 363
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our relationship with the fda is important to us. and we're committed to fully engaging to address concerns. lauren allegra health policy advisor at practice fusion a company providing services to practitioners and patients. >> the company could do more work which is a recommendation from policy folks. and that might push it into a court case. >> abc7, carolyn? >> thank you very much. a major set back tonight that could put california high speed rail project in dep di. one blocked the sale of $8 billion in bonds the judge said there is no evidence bond sale was necessary he ruled in favor of a lawsuit claiming the lawsuit no longer resemble what's voters voted for. stopping short of blocking the project but did order the authority to redo it's $68 billion spending plan. that could take years. >>> a massive yub liptus tree has been transformed into oakland's newest playground. take a look. those winds knocked the tree on its side and since then, kids, adult asks just about everyone have been climbing on the tree. so massive, the root
our relationship with the fda is important to us. and we're committed to fully engaging to address concerns. lauren allegra health policy advisor at practice fusion a company providing services to practitioners and patients. >> the company could do more work which is a recommendation from policy folks. and that might push it into a court case. >> abc7, carolyn? >> thank you very much. a major set back tonight that could put california high speed rail project in dep di. one...
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Nov 13, 2013
11/13
by
CSPAN2
tv
eye 85
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fda. outsourcing facilities are subject to regular fda inspections. the new england compounding center problems were not inspected by the state or the fda from 2006 to 2011. outsourcing facilities must report to products made at the facility to the fda. the new england center that caused the problems was making copies of commercially available drugs. facilities must report to the fda when things go wrong with a product. currently large sale compound or stone have required reporting to the fda if they know about a problem with the product. finally outsourcing facilities is a new category must clearly label their products so patients know what is compounded is fda approved. traditional pharmacy compactors will continue to be regulated by the states but for outsourcing facilities the fda is in charge. during our discussions we heard a lot about drug shortages and the senator from iowa and i worked especially to deal with that. we try to address it where appropriate in this legislation. we know that compounded products aren't the answer to drug shortages
fda. outsourcing facilities are subject to regular fda inspections. the new england compounding center problems were not inspected by the state or the fda from 2006 to 2011. outsourcing facilities must report to products made at the facility to the fda. the new england center that caused the problems was making copies of commercially available drugs. facilities must report to the fda when things go wrong with a product. currently large sale compound or stone have required reporting to the fda...
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55
Jul 28, 2013
07/13
by
CSPAN2
tv
eye 55
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and it, and there are organizations out there that are can constantly watching the fda, suing the fda when they feel it's necessary. and these are good, these public interest organizations help us. and every once in a while they sue the fda, and the courts say you're right, the fda hasn't done enough. so that's the way our system seems to be where you, you know, you have good people working for the agency, but not all their decisions can be reached at the top levels. and the fda makes mistakes. when they do, they pull a drug off the market. sometimes those mistakes are because lack of information, sometimes it's because the drug companies don't reveal the information, and then they get sued. so there's all kinds of reasons why sometimes drugs get on the market that they shouldn't be or sometimes food add tyes -- additives get into our food, and they shouldn't be. it's a good question though. have to be vigilant. >> it's very difficult to trust the fda. [laughter] um, it's changed a great deal since the time when it protected americans from the ravages of the lid mid. the fdi did not a
and it, and there are organizations out there that are can constantly watching the fda, suing the fda when they feel it's necessary. and these are good, these public interest organizations help us. and every once in a while they sue the fda, and the courts say you're right, the fda hasn't done enough. so that's the way our system seems to be where you, you know, you have good people working for the agency, but not all their decisions can be reached at the top levels. and the fda makes mistakes....
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Oct 24, 2013
10/13
by
KPIX
tv
eye 187
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fda has the authority to institute an import ban on these products. they are not doing that though. they are letting the products stay in the market. >> we have really been moving away from them for about 2.5 to 3 years now. >> reporter: locally run stores like pet food express are instituting a sort of voluntary import banff their own ban choosing to sell u.s.-made treats. chains we visited today say they are still selling the treats because there's no recall. so in the meantime, dogs continue to get sick and the fda continues to issue warnings. and grieving pet owners nationwide ar furious. >> i think they should make whoever made them eat them, themselves. >> reporter: the fda says there's nothing keeping stores and manufacturers from issuing a voluntary recall until the agency finds the source of the illness but stores and manufacturers say they believe the treats are safe. find the full responses at kpix.com/consumerwatch. >> it says clearly on those packages made in china? >> it does on these packages. but, you know, i have to say that they don'
fda has the authority to institute an import ban on these products. they are not doing that though. they are letting the products stay in the market. >> we have really been moving away from them for about 2.5 to 3 years now. >> reporter: locally run stores like pet food express are instituting a sort of voluntary import banff their own ban choosing to sell u.s.-made treats. chains we visited today say they are still selling the treats because there's no recall. so in the meantime,...
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Jan 6, 2013
01/13
by
FOXNEWSW
tv
eye 47
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a gap between the fda and the department of agriculture. by the time it's food, it may be contaminated. there's a two-prong attack, one on the food manufacturers and the other on the farms. the farms look at the four w's. david loves the four w's, water, waste, workers and wild animals. water is contamination of irrigation. workers, did you wash your hands. wild animals, what animals are getting into the farmland. waste, do you have toilets off the field so you don't get contaminated that way. those are the key things. >> it's also important to make sure not just protect ourself here but we get 15% of our food resources coming from outside. and you got to basically hold them to the same standard. that's the way we'll protect the public. >> is washing enough? >> another thing that farmers are going to be looking into is the cost. everybody is in favor of safe food, but anytime you introduce new regulations and rules it means farmers have to spend more to follow the rules and the costs get passed down to us. >> they estimate $30,000 per large
a gap between the fda and the department of agriculture. by the time it's food, it may be contaminated. there's a two-prong attack, one on the food manufacturers and the other on the farms. the farms look at the four w's. david loves the four w's, water, waste, workers and wild animals. water is contamination of irrigation. workers, did you wash your hands. wild animals, what animals are getting into the farmland. waste, do you have toilets off the field so you don't get contaminated that way....
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Jun 15, 2013
06/13
by
CSPAN2
tv
eye 99
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i guess the fda -- should the fda remove roadblocks to manufacturers who want to produce bruce detercht drugs so they can speed the new formula to market to reduce overall abuse? >> yes, we should. i view the technology and couraging their use in opioid as an incremental progress. process. we beginning to walk a road i hope to see a broad majority in abuse deterrent formulation. that's going depress your concern. the squeezing balloon. people moving from an abuse deterrent formulation to another formulation that is easier to abuse. in the short term, here i think we be fooling ourselves if we imagined it wasn't going happen. so my job, i think i guess our agency's job is incentivize the development of new technology broadly and to make certain those technologies demonstrate they work. so we should be developing abuse successfully reduce abuse through reviewing of the data, i believe the fda plays a critical role there. >> let me go to dr. clark. how can we educate health care providers to spot the warning signs. the warning signs of frequent fliers who might not have a legitimate need f
i guess the fda -- should the fda remove roadblocks to manufacturers who want to produce bruce detercht drugs so they can speed the new formula to market to reduce overall abuse? >> yes, we should. i view the technology and couraging their use in opioid as an incremental progress. process. we beginning to walk a road i hope to see a broad majority in abuse deterrent formulation. that's going depress your concern. the squeezing balloon. people moving from an abuse deterrent formulation to...
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Apr 13, 2013
04/13
by
KNTV
tv
eye 144
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gnc also says it does not sell substances banned or recalled by the fda. while dmaa has not been officially band. the u.s. military prohibited selling it on bases when five months after michael sparling collapsed, a second soldier died after use can dmaa. nine countries, including canada and the uk have banned it. >> canada has banned it. the u.s. military has taken the substance out of all of its shops but you can still get it at the local store. >> it's absurd. >> the sparlings say they are waiting for the fda to demand dmaa. they are suing usp labs and gnc for causing their son's death. for the past two years, leann, with michael's dog tags around her neck, has been dropping into supplement stores to find out if they are still selling jacked. she told us about a conversation she had with a clerk a few months after michael's death. >> i said, i'm interested in a product called jacked 3-d. he goes, oh, yes. this is our top seller. >> i said, have you heard of any adverse side ekt ifs? he goes, no, it is 100% natural. it is totally safe. he goes, are you b
gnc also says it does not sell substances banned or recalled by the fda. while dmaa has not been officially band. the u.s. military prohibited selling it on bases when five months after michael sparling collapsed, a second soldier died after use can dmaa. nine countries, including canada and the uk have banned it. >> canada has banned it. the u.s. military has taken the substance out of all of its shops but you can still get it at the local store. >> it's absurd. >> the...
99
99
Dec 16, 2013
12/13
by
CSPAN2
tv
eye 99
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from the regulatory side, i spend every thursday afternoon at the fda. [laughter] talking through things. we have regular meetings with our office of engineering and technology. and, you know, we did a workshop with them recently, we're going to do some workshops on things like wireless in the future. so it's a technical conversation, but it's also, you know, getting to know people individually and personally conversation. >> host: you brought up the health care connect fund, so give us a status report on rural areas across the united states. how equipped are they to handle these new technologies? >> guest: well, there's two sides to this. one of them is health care organizations themselves. so the institutions and connecting those. and we're getting a lot of progress on broadband to those folks. there are still some gaps, as commissioner clyburn talked about earlier, in getting broadband to people individually. and the fcc has taken some pretty exciting actions in that regard through the other programs. the other is just getting phones in people's hands
from the regulatory side, i spend every thursday afternoon at the fda. [laughter] talking through things. we have regular meetings with our office of engineering and technology. and, you know, we did a workshop with them recently, we're going to do some workshops on things like wireless in the future. so it's a technical conversation, but it's also, you know, getting to know people individually and personally conversation. >> host: you brought up the health care connect fund, so give us a...
70
70
Nov 26, 2013
11/13
by
KOFY
tv
eye 70
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our relationship with the fda is important to us. and we're committed to fully engaging to address concerns. lauren allegra health policy advisor at practice fusion a company providing services to practitioners and patients. >> the company could do more work which is a recommendation from policy folks. and that they might push it into a court case. >> abc7, carolyn? >> thank you very much. a major set back tonight that could put california high speed rail project in dep di. one blocked the sale of $8 billion in bonds the judge said there is no evidence bond sale was necessary he ruled in favor of a lawsuit claiming the lawsuit no longer resemble what's voters voted for. stopping short of blocking the project but did order the authority to redo it's $68 billion spending plan. that could take years. >>> a massive yub liptus tree has been transformed into oakland's newest playground. take a look. those winds knocked the tree on its side and since then, kids, adult asks just about everyone have been climbing on the tree. so massive, the
our relationship with the fda is important to us. and we're committed to fully engaging to address concerns. lauren allegra health policy advisor at practice fusion a company providing services to practitioners and patients. >> the company could do more work which is a recommendation from policy folks. and that they might push it into a court case. >> abc7, carolyn? >> thank you very much. a major set back tonight that could put california high speed rail project in dep di....
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fda officials didn't receive money directly. they got cozy with the pharmaceutical representatives that came there, some did go on "the washington post" said, to become consultants and get paid by them later. this cozy relationship when we're talking about, you know addictive drugs. >> yes, yes because in particular here we're talking about painkillers which is sort of the point of this article. it is very problematic when they start getting too cozy. you know what? it is government-wide, melissa. you talk about the resolving door, people leave government and go into lobbying and lobbying old colleagues and so on this. is another example. this is more dangerous. we're talk about addictive drugs going to t marketplace. >> the other problem with this idea of having meetings to open to everyone, as we say in washington as soon as it is open meeting less gets done. this is always the argument. >> i'm all for openness, there are things to try to get a scientific consensus, like national security, a lot of things have to behind closed
fda officials didn't receive money directly. they got cozy with the pharmaceutical representatives that came there, some did go on "the washington post" said, to become consultants and get paid by them later. this cozy relationship when we're talking about, you know addictive drugs. >> yes, yes because in particular here we're talking about painkillers which is sort of the point of this article. it is very problematic when they start getting too cozy. you know what? it is...
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33
May 12, 2013
05/13
by
FOXNEWSW
tv
eye 33
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i like where the fda is going here. i worry it will only get on pamphlets and won't get to people who go to these things. 2.3 million teenagers using tanning salons. increases melanoma, nonmelanoma, why do people need these tanning salons. there's compelling scientific evidence dem stralgt ultraviolet radiation from indoor tanning devices is associated with increased risk of melanoma and nonmelanoma skin cabser. in fact, the risk of developing melanoma the deadliest form of skin cancer increases 75% for individuals who have bern exposed to uv radiation from indoor tanning and the risk increases with each use. it's both kinds of ultraviolet light. >> what about protection? those places sell sunscreen. >> fda does say less amount of time you're in there better. maybe in some cases these devices work, maybe they don't. best use is to avoid. fda stepping up regulation, indoor tanning, wait a minute, we're losing money. what about the economy? this is unsafe. this is dangerous. >> suntan lotions won't work. 65% of the people
i like where the fda is going here. i worry it will only get on pamphlets and won't get to people who go to these things. 2.3 million teenagers using tanning salons. increases melanoma, nonmelanoma, why do people need these tanning salons. there's compelling scientific evidence dem stralgt ultraviolet radiation from indoor tanning devices is associated with increased risk of melanoma and nonmelanoma skin cabser. in fact, the risk of developing melanoma the deadliest form of skin cancer...
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115
Feb 24, 2013
02/13
by
CNNW
tv
eye 115
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. >> there are over 140 drugs out there that the fda has identified as possibilities. and are in some stage of being looked at right now. >> why are they holding back? >> 140. there's got to be one or a combination thereof that can slow down this virus or halt it in its tracks. >> you know, i mean -- and we now know, again, what you said was true. there were some very effective medications. and i don't know if the correct way of describing it is that they were being sat on, but do you think -- peter, let me ask you, act up changed the trajectory of the drug approval process, because this is a cumbersome process in this country. >> indeed. and, you know, up until that point, it usually took a pharmaceutical company upwards of ten years to get a drug approved by the fda. we pushed them and got that down to a matter of months. but the real key was getting the federal government to actually spend some money on aids research, which they hadn't been doing much of prior to act up. and once we started pushing aids into the national agenda and the national consciousness, the bu
. >> there are over 140 drugs out there that the fda has identified as possibilities. and are in some stage of being looked at right now. >> why are they holding back? >> 140. there's got to be one or a combination thereof that can slow down this virus or halt it in its tracks. >> you know, i mean -- and we now know, again, what you said was true. there were some very effective medications. and i don't know if the correct way of describing it is that they were being sat...
201
201
Jun 7, 2013
06/13
by
KNTV
tv
eye 201
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the fda has now tested about 300 samples. the agents still haven't identified any contaminants. inspectors found trace amounts of a type of antibiotic not approved in the u.s. that prompts two major makers to recall their treats. >> the trace amounts of antibiotic residue to not pose a health safety risk. the investigative unit found those and kingdom pets were among the brands with the most complaints between 2007 and 2012. on its web site, we hold our pruktss to the highest quality and standards are. kingdom pets posts results on its site. >> between 2003 and 2011,the volume of pet groups grew 85 fomd. >> thousands of u.s. pets have died. part of the problem is some of our companies are willing to take advantage of china's lax safety measures. >>> when asked if he would buy dog treats from china, solomon towed the fb ix line. >> meanwhile, the fda has not put in place a key part of the food safety modernization act signed into law in 2011. the law says any time the fda identifies a food for people or animals, it must be removed and stores must post a sign at the rej sfer. the
the fda has now tested about 300 samples. the agents still haven't identified any contaminants. inspectors found trace amounts of a type of antibiotic not approved in the u.s. that prompts two major makers to recall their treats. >> the trace amounts of antibiotic residue to not pose a health safety risk. the investigative unit found those and kingdom pets were among the brands with the most complaints between 2007 and 2012. on its web site, we hold our pruktss to the highest quality and...
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114
Apr 20, 2013
04/13
by
CSPAN
tv
eye 114
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the fda approved, for example, for women -- there is no fda approved testosterone for women. it has been shown conclusively that women have a higher risk for heart disease and cancer if their testosterone levels are too high. approved is no fda testosterone medication for it. the only way to provide that to those women is to use a compounded medication. forfda approved medications menopausal women who have problems, the recommendation from the large organizations, the american menopause society, is to get the lowest dose possible for the shortest period of time, but their own scientific literature shows are optimal levels beneficial for the women. the fda approved medications do not reach those therapeutic levels. host: anna edney. guest: you make a good point. ares a question that people asking, particularly republicans in the house. they have not gotten behind any effort for legislation. they're asking -- that's why they held the steering -- what could he fda do with the powers they already have. doe wanto give them more? am thinking the states should be able to retain what
the fda approved, for example, for women -- there is no fda approved testosterone for women. it has been shown conclusively that women have a higher risk for heart disease and cancer if their testosterone levels are too high. approved is no fda testosterone medication for it. the only way to provide that to those women is to use a compounded medication. forfda approved medications menopausal women who have problems, the recommendation from the large organizations, the american menopause...
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134
Nov 26, 2013
11/13
by
KGO
tv
eye 134
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the fda thinks the service falls under medical device category. because consumers can act on the results as a diagnosis. >> patients don't know how to interpret results and don't understand it's going to signify risk. >> 23 and me issued a statement saying in part we recognize we have not met the fda expectations regarding time line and communications regarding our submission. our relationship with the fda is extremely important to us and we're committed to fully engaging with them to address concerns. the company has 15 days to satisfy demands, one possible scenario is that it could end hashing it out in the courtroom. >>> a report on the sandy hook massacre indicates no motive for the attack and reveals it took police nearly six minutes to enter the school after the shooting was first reported. that report found the gunman was obsessed with the 1999 columbine high school assault. he had mental issues that affected his ability to live a normal live and interact with others but how those issues contributed to the shootings is still unclear to inve
the fda thinks the service falls under medical device category. because consumers can act on the results as a diagnosis. >> patients don't know how to interpret results and don't understand it's going to signify risk. >> 23 and me issued a statement saying in part we recognize we have not met the fda expectations regarding time line and communications regarding our submission. our relationship with the fda is extremely important to us and we're committed to fully engaging with them...
74
74
Mar 9, 2013
03/13
by
CSPAN
tv
eye 74
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we are fda's law enforcement arm. the conduct a variety of investigations involving all fda regulated -- including dietary supplements. for those of you who do not really know the structure and framework of the fda, basically speaking, there are six backbone's of the fda located here in maryland. each center is responsible for overseeing and regulating particular commodities. those six centers are the center for biologics evaluation and research, the center for veterinary medicine, the center for devices and radiological health, the center for tobacco products, the center for food safety and applied nutrition, and a center for drugs evaluation and research. dietary supplements primarily are regulated by the center for food safety and applied nutrition. however, in my line of work, in the drug arena, at certain times, those dietary supplements are under the purview of the center for drugs. the types of criminal investigations that i see involving a dietary supplements are twofold. we have tainted dietary supplements. t
we are fda's law enforcement arm. the conduct a variety of investigations involving all fda regulated -- including dietary supplements. for those of you who do not really know the structure and framework of the fda, basically speaking, there are six backbone's of the fda located here in maryland. each center is responsible for overseeing and regulating particular commodities. those six centers are the center for biologics evaluation and research, the center for veterinary medicine, the center...